Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

nGAP lecturers welcomed by the UFS academic community
2016-06-30

Description: nGAP lecturers group photo Tags: nGAP lecturers group photo

University of the Free State’s newly-appointed nGAP
lecturers. From the left, Neo Mathinya,
Phumudzo Tharaga, and Kelebogile Boleu.

The University of the Free State (UFS) was allocated six positions as part of the Department of Higher Education and Training (DHET) New Generation of Academics Programme (nGAP). Four candidates have filled positions in the Faculty of Health Sciences, Faculty of the Humanities and the Faculty of Natural and Agricultural Sciences – with two positions still vacant.

According to Minister of Higher Education and Training, Dr Blade Nzimande, nGAP is part of the Staffing South Africa's Universities Framework, which focuses on the expansion of the size and compilation of academic staff at South African universities, especially with regard to transformation. The focus of the programme is the appointment of black and coloured candidates as well as women.

The Department of Soil, Crop, and Climate Sciences in the Faculty of Natural and Agricultural Sciences welcomed two nGAP lecturers, Phumudzo Tharaga and Neo Mathinya. The Faculty was allocated four positions. Two positions are filled, while two positions in the Department of Animal and Wildlife Sciences are almost ready to be filled with exceptional candidates.

Agrometeorologist with his feet on the ground
Phumudzo Tharaga holds an MSc from the UFS, and is currently pursuing a PhD. Tharaga’s research focuses on quantifying the water use efficiency of sweet cherry orchards under different climate conditions in the Eastern Free State. Tharaga will offer his students a wealth of practical experience, which he began accumulating while working at ABSA as an agro-meteorologist, before moving on to become a senior scientist at the South African Weather Service. In 2015, Tharaga became a research technologist at the Council for Scientific and Industrial Research (CSIR) and then returned to the UFS as an nGAP candidate at the beginning of 2016.  

Description: Beynon Abrahams, nGap lecturer  Tags: Beynon Abrahams, nGap lecturer

Beynon Abrahams, nGap lecturer
at the Faculty of Heath Sciences
Department of Basic medicine

Motivated scholar turned academic
Neo Mathinya, who hails from Taung in the North West, has made the UFS her home. She received both her undergraduate and honours degrees from the university. Apart from joining the department as a lecturer under the nGAP initiative, she is currently studying for her MSc in Soil Physics. She will continue with this research when she comes to her PhD. Mathinya’s research focuses on soil salinity - the process of increasing salt content - which affects the ability of plants to take up water, a process, known as osmotic stress. She will investigate the effects of irrigation water salinity on the grain yield and quality of malt barley.

Researcher with a passion for crime prevention
Kelebogile Boleu joined the Department of Criminology in the Faculty of Humanities, with a fresh take on diversion and crime prevention. Boleu holds a BA Criminology (Hons) and is now pursuing her Master’s degree. She worked for NICRO a non-profit organisation specialising in social crime prevention and offender reintegration, with programmes that prevent young and first-time offenders from re-offending, thus reducing crime. Boleu said that her practical experience makes her lectures to third-year criminology students exciting. Boleu’s research focuses on analysing the value of pre-sentencing reports in assisting adjudicators to make well-balanced judgments in cases.   

Research with a winning plan for fight against breast cancer
Beynon Abrahams joined the Department of Basic Medical Sciences in the Faculty of Health Sciences. Abrahams holds a BSc, BSc (Hons), and MSc in Medical Biosciences from the University of the Western Cape. Abrahams’ Master’s research focused on breast cancer, research on which he is building in his PhD. This doctoral research involves the exploration of P-glycoprotein, a protein expressed on cancer cell and responsible for multi-drug resistance in cancer treatment. The aim of this research is to develop a therapeutic drug treatment strategy that will improve breast cancer patient survival outcomes. Abrahams’s greater vision is to look at conventional cancer therapeutic regimens, to find ways in which they can be improved.

The nGAP initiative offers these young lecturers an opportunity for growth and development as academics, while providing them with opportunities they would have not have been exposed to otherwise.

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept